Talk to an Intellectual Property Lawyer

[NOTE: In September 2011, the U.S. enacted the America Invents Act that bars the issuance of patent claims directed to or encompassing a human organism.]

Ordinarily, patents will not be issued on “inventions”
consisting of items or substances that are found to exist in a natural state.
The reason for this is obvious. Something occurring in nature without human
intervention cannot have been the product of inventive activity.

There are several categories of patentable inventions that
do, however, involve “natural” materials. One category is novel and nonobvious
plants created through asexual breeding. Plant patents for new plants involving
human inventiveness (breeding skill) are specifically authorized by statute
(the patent laws and the Plant Variety Protection Act) in the United States.

Genetic engineering is another field where “natural”
materials (that is, bacteria, DNA, RNA) have been manipulated by humans through
gene splicing and cloning techniques (such as Polymerase Chain Reaction, or
PCR) to produce new organic materials and life forms. These new substances and
forms, and the processes used to create them, are also considered to be
patentable under authority of the U.S. Supreme Court’s decision in the case of Diamond
v. Chakrabarty, 447 U.S. 303 (1980), as long as they meet the basic
patent requirements of novelty, nonobviousness, and utility.

Because Congress wants basic research in biotechnology to
develop as quickly as possible, federal law permits a company to utilize
biotechnical inventions patented by another company if the purpose of the use
is strictly for research. This is an exception to the general rule that a
patent prohibits the manufacture or use of an invention covered by an in-force
patent. If, however, the company doing the research desires to commercially
exploit the substance or process being utilized, it must obtain permission from
the patent owner (usually accomplished by paying a license fee).

In 2010 a federal district court determined that certain
patent claims for BRCA1 and BRCA2 human genes were invalid. The genes are found
in the cells of breast and other tissue, where they help repair damaged DNA.
The genes are a factor in breast cancer diagnosis. The court held that the
subject matter was unpatentable because genes are the physical embodiment of
[genetic] information. (In Association
for Molecular Pathology v. USPTO, 702 F. Supp. 2d 181 (S.D.N.Y. 2010)).